Anastomotic Leakage
Conditions
Brief summary
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate
Detailed description
The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.
Interventions
DEVICELifeSeal® Kit
used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.
Sponsors
LifeBond Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age at screening visit 2. Written informed consent obtained 3. Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis\* created within 15 cm from the anal verge. 4. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU
Exclusion criteria
1\. Subject with American Society of Anesthesiology (ASA) status \> 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-operative clinical anastomotic leaks at discharge | discharge from hospital 3-14 days post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery | up to 4 weeks post surgery |
Countries
Belgium, Netherlands
Outcome results
None listed